Broncoral Neo 12 micrograms/puff solution for inhalation in pressurised container

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

BRONCORAL NEO 12 micrograms/dose Inhalation solution in pressurized container

Formoterol fumarate dihydrate

Read this entire leaflet carefully before you start using this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

1. What BRONCORAL NEO is and what it is used for
2. What you need to know before using BRONCORAL NEO
3. How to use BRONCORAL NEO
4. Possible adverse effects
5. How to store BRONCORAL NEO
6. Contents of the pack and other information

1. What Broncoral Neo is and what it is used for

Broncoral Neo is an inhaled medicine that delivers the active ingredient directly to your lungs. It is used to treat wheezing and breathing difficulties in patients with moderate to severe asthma. Its active ingredient, formoterol fumarate, belongs to a group of medicines called bronchodilators, which make breathing easier by relaxing spasms in the muscles of the airways in the lungs. Regular use of Broncoral Neo, together with corticosteroids (either inhaled or oral), will help prevent long-term breathing problems.

Broncoral Neo may also be used to relieve symptoms such as cough, wheezing, and shortness of breath in patients with chronic obstructive pulmonary disease (COPD) who require regular long-term treatment with bronchodilators.

2. What you need to know before using BRONCORAL NEO

Do not use Broncoral Neo:

• if you are allergic to formoterol or any of the other ingredients of this medicine (listed in section 6).
• to treat a sudden asthma attack. It will not help you. Use a rescue inhaler for this purpose and always carry it with you.

Warnings and precautions

Talk to your doctor or pharmacist before starting to use Broncoral Neo if:

• you have a serious heart condition, especially if you have recently had a heart attack, coronary heart disease, or severe weakening of the heart muscle (congestive heart failure)
• you have heart rhythm disorders, such as increased heart rate, heart valve abnormalities, certain electrocardiographic abnormalities, or any other heart disease
• you have narrowing of blood vessels, especially arteries, or abnormal thickening of the vessel wall
• you have high blood pressure
• you have high blood sugar levels (diabetes mellitus)
• you have low potassium levels in the blood
• you have overactivity of the thyroid gland
• you have adrenal cortex tumors, whether or not they produce epinephrine
• you are about to undergo surgery or receive halogenated anesthetics.

Other medicines and Broncoral Neo

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Some medicines may interfere with the action of Broncoral Neo, such as:

• medicines for heart rhythm disorders (e.g., quinidine, disopyramide, procainamide)
• medicines for heart conditions (e.g., digitalis)
• medicines for nasal congestion (e.g., ephedrine)
• adrenergic beta-blockers used to treat heart conditions or glaucoma (increased eye pressure), whether in tablet form or eye drops
• those containing erythromycin (used to treat infections)
• medicines for depression symptoms: monoamine oxidase inhibitors (e.g., phenelzine, isocarboxazid) or tricyclic antidepressants (e.g., amitriptyline, imipramine)
• medicines for severe psychiatric disorders (e.g., chlorpromazine, triflupromazine)
• medicines for allergic reactions (such as antihistamines, e.g., terfenadine, astemizole, mizolastine)
• medicines for bronchial asthma (e.g., theophylline, aminophylline, or corticosteroids)
• medicines that stimulate urine production (such as diuretics)
• medicines for Parkinson's disease (e.g., levodopa)
• those containing oxytocin, which causes uterine contractions
• medicines for underactive thyroid gland (e.g., thyroxine)

The addition of anticholinergics (such as tiotropium or ipratropium bromide) to treatment with Broncoral Neo may help further open the airways.

You have also been prescribed corticosteroids for your respiratory problems. It is very important that you continue to use them regularly. Do not stop using them or change the dose when you start taking Broncoral Neo.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

The use of Broncoral Neo during pregnancy is only indicated if absolutely necessary.

Driving and using machines

It is unlikely that Broncoral Neo will have any effect on your ability to drive or use machines.

Broncoral Neo contains ethanol

This medicine contains small amounts of ethanol (alcohol): 8.9 mg of alcohol (ethanol) per spray, corresponding to 0.25 mg/kg per two-spray dose in adults and equivalent to 0.44 mg/kg per two-spray dose in adolescents. The amount in two sprays of this medicine is less than 1 ml of wine or beer. The small amount of alcohol in this medicine has no noticeable effects.

3. How to use BRONCORAL NEO

Follow exactly the administration instructions for this medicine as given by your doctor. If in doubt, consult your doctor.

Asthma

The dose of Broncoral Neo you should inhale depends on the type and severity of your asthma. Your dose will be determined by your doctor, and it is important that you take only the prescribed dose regularly.

The usual dose for adults, including elderly patients and adolescents aged 12 years and older, is 1 puff in the morning and 1 puff at night. This means you need to take a total daily dose of Broncoral Neo of 2 puffs (24 micrograms).

If you have more severe asthma, your doctor may prescribe 4 puffs per day (48 micrograms), 2 puffs in the morning and 2 puffs at night.

The maximum daily dose of Broncoral Neo is 48 micrograms (4 puffs), and it is important that you do not exceed the total daily dose prescribed by your doctor.

This product is not suitable for asthmatic children under 12 years of age.

Chronic Obstructive Pulmonary Disease (COPD)

The usual dose for adults (over 18 years of age), including elderly patients, is 1 puff in the morning and 1 puff at night. This means you need to take a total of 2 puffs (24 micrograms) of Broncoral Neo per day.

If you have more severe COPD, your doctor may prescribe 4 puffs per day (48 micrograms), 2 puffs in the morning and 2 puffs at night.

The maximum daily dose of Broncoral Neo is 48 micrograms (4 puffs), and it is important that you do not exceed the total daily dose prescribed by your doctor.

Do not take more than 2 puffs at the same time.

This product is not suitable for patients with COPD under 18 years of age.

Do not use Broncoral Neo to treat an acute asthma attack. For this purpose, you should use a "rescue" inhaler prescribed by your doctor, which you must always carry with you.

If you use more Broncoral Neo than you should

You may notice an increased heart rate and experience tremors. You may also suffer headache, tremors, nausea and vomiting, or feel drowsy. Inform your doctor as soon as possible.

If you forget to use Broncoral Neo

If you forget to take Broncoral Neo, take it as soon as you remember. If it is almost time for your next dose, do not take the missed dose and continue with your usual dosing schedule. Do not take a double dose to make up for a missed dose.

Do not stop or reduce the dose of Broncoral Neo or any other medication for your respiratory condition just because you feel better, without first consulting your doctor. It is very important to use these medicines regularly.

Do not increase your dose of Broncoral Neo without first consulting your doctor.

If you feel you are having difficulty breathing or wheezing while using Broncoral Neo, you should continue using Broncoral Neo but visit your doctor as soon as possible, as you may need additional treatment. Once your asthma is well controlled, your doctor may consider gradually reducing the dose of Broncoral Neo.

Instructions for use

It is important that you know how to use your inhaler correctly. Your doctor, nurse, or pharmacist will show you how to use your inhaler properly. You must carefully follow their instructions to learn how, when, and how many puffs to administer. Correct instructions are detailed in this leaflet. If you are unsure how to proceed or have difficulties with inhalation, consult your doctor, nurse, or pharmacist.

Checking your inhaler. If your inhaler is new, or has not been used for 3 days or more, you should release one puff into the air to ensure it is working properly.

Whenever possible, you should be standing or sitting upright when taking your inhalation.

1.- Remove the protective cap from the mouthpiece of the inhaler and hold it between your thumb and index finger as shown.

2.- Breathe out as deeply as possible.

3.- Hold the canister vertically, as shown, with your thumb on the base of the mouthpiece; place the inhaler in your mouth, between your teeth, and close your lips firmly around it.

4.- Breathe in deeply through your mouth and, at the same time, press down on the top of the inhaler to release one puff.

5.- Hold your breath for as long as you can without causing yourself discomfort, and then remove the inhaler from your mouth.

1. If another inhalation is required, keep the inhaler in an upright position and wait for half a minute, then repeat steps 2 to 5.
2. After use, replace the protective cap to prevent contamination. Securely attach it and leave it in place.

1 2 3 4 5-6

IMPORTANT: Do not perform steps 2, 3, 4, and 5 too quickly.

Before inhaling, it is important that you breathe in as slowly as possible.

If gas escapes from the top of the inhaler or from the corners of your mouth, Broncoral Neo will not reach your lungs properly. In this case, take another puff carefully, following the instructions starting from step 2.

If you have weak hands, you may find it easier to hold the inhaler with both hands. Place both index fingers on the top of the inhaler and both thumbs underneath it.

If you experience any difficulty, consult your doctor, nurse, or pharmacist.

Cleaning the inhaler

It is important to clean the inhaler regularly—at least once or twice a week—to ensure proper functioning.

• Remove the aluminum canister from the plastic inhaler and take off the protective cap from the mouthpiece.
• Rinse the plastic inhaler and protective cap with lukewarm water.
• Do not wet the aluminum canister with water.
• Dry the inhaler and protective cap thoroughly in a warm place. Avoid excessively high temperatures.
• Reinsert the aluminum canister and replace the protective cap on the mouthpiece.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them. The possible adverse effects are listed below according to their frequency. If you are unsure about the adverse effects mentioned, consult your doctor so that they can explain them to you.

If you experience worsening of breathing difficulty or wheezing after using the inhaler, stop using Broncoral Neo and inform your doctor immediately. This is caused by narrowing of the airways in your lungs, although it occurs only rarely.

Frequent (affects at least 1 in every 10 people):

• exceptionally, rapid heartbeat and palpitations, cough, tremors (mild trembling), headache.

Uncommon (affects at least 1 in every 100 people):

• muscle cramps, muscle pain, nausea, agitation, nervousness, sleep disturbances, dizziness, taste disturbances, throat irritation, increased heart rate, cardiac rhythm disorders with increased heart rate, decreased blood potassium levels, increased blood sugar levels, increased blood levels of insulin, free fatty acids, glycerol and ketones, excessive sweating.

Rare (affects at least 1 in every 1,000 people):

• absence of heartbeat caused by premature contraction of the heart's ventricles, sensation of chest tightness, increased or decreased blood pressure, bronchial muscle spasm after using inhaled medicines, severe drop in blood pressure, kidney inflammation, hypersensitivity reactions such as itching, skin rash, bronchospasm, urticaria, swelling of the skin and mucous membranes lasting several days.

Very rare (affects at least 1 in every 10,000 people):

• acute worsening of asthma, breathing difficulty, swelling of the hands and/or feet, irregular heartbeat, reduced platelet count, hyperexcitability, abnormal behavior, hallucinations.

Some adverse effects, such as tremors, nausea, taste disturbances, throat irritation, excessive sweating, nervousness, headache, dizziness, and muscle cramps, may resolve spontaneously after one to two weeks of continued treatment.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es.

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of BRONCORAL NEO

• Keep this medicine out of the sight and reach of children.

• Do not use this medicine after three months from the date of purchase at the pharmacy, or after the expiry date stated on the carton and label. The expiry date refers to the last day of the month indicated.

• Do not store at temperatures above 30°C.

• If the inhaler is very cold, remove the aluminum canister from the inhaler and warm it by holding it in your hands for a few minutes before use. Never use any other source of heat.

• Caution. The aluminum canister contains pressurized liquid. Do not expose to temperatures above 50°C. Also, do not pierce the container.

• Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point in your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Broncoral Neo

• The active substance in Broncoral Neo is formoterol fumarate dihydrate. Each actuation delivers 12 micrograms of formoterol fumarate dihydrate. This corresponds to a delivered dose of 10.1 micrograms.
• The other components are: hydrochloric acid, ethanol, and norflurane (HFC-134a).

This medicinal product contains fluorinated greenhouse gases.

Each 50-actuation inhaler contains 5.842 g of norflurane (HFC-134a), equivalent to 0.008 tonnes of CO2 (global warming potential GWP = 1430).

Each 100-actuation inhaler contains 9.087 g of norflurane (HFC-134a), equivalent to 0.013 tonnes of CO2 (global warming potential GWP = 1430).

Each 120-actuation inhaler contains 10.384 g of norflurane (HFC-134a), equivalent to 0.015 tonnes of CO2 (global warming potential GWP = 1430).

Nature of the product and contents of the container

Broncoral Neo is available as an inhalation solution in a pressurized aluminum container equipped with a plastic inhaler and a protective cap.

Each pack contains 1 inhaler delivering 50, 100, or 120 actuations.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Chiesi España, S.A.U.

Plaça d’Europa, 41-43, Planta 10

08908 L’Hospitalet de Llobregat

Barcelona (Spain)

Manufacturer and Batch Release Responsible

Chiesi Farmaceutici S.p.A., Via San Leonardo 96, 43122 Parma, Italy

Alternative Manufacturer and Batch Release Responsible

Chiesi Pharmaceuticals GmbH, Gonzagagasse 16/16, 1010 Wien, Austria

This medicinal product has been authorized in the following European Economic Area Member States and in the United Kingdom (Northern Ireland) under the following brand names:

Date of the most recent review of this leaflet: July 2024.

Detailed information about this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS): http://www.aemps.gob.es.